MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Bent (1059)

Patient Problem Death (1802)

Event Date 06/07/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient passed away.It was reported that the cause of death was unknown as the coroner did not find anything during the autopsy.The patient passed away at home.The generator and lead were explanted and returned for analysis.Analysis of the lead was completed on 06/28/2016.The connector pin is bent.Note that since a significant portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.Analysis of the generator is underway, but has not been completed to date.The generator was previously reported in mfr.Report # 1644487-2016-00620.

Manufacturer Narrative

The initial report inadvertently did not report the patient's seizure history prior to passing.

Event Description

The patient's family indicated the patient had grand mal seizures on (b)(6) 2016.It was reported that on (b)(6) 2016, the patient had seizure and stopped breathing with subsequent intubation.Then around (b)(6) 2016, the patient had an issue where the friend called 911 due to a seizure and was hospitalized for three days.Review of the generator seizure log data notes that there were no autostimulation noted (b)(6) 2016.No additional relevant information has been received to date.

Event Description

Analysis of the explanted generator was completed.Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery showed an ifi=no condition.Mfg report # 1644487-2016-00620 captures the report of undersensing.

Manufacturer Narrative

Explant date, corrected data: the supplemental report #2 inadvertently did not update the date of explant based on received information.

Event Description

Per the data dump, the "change in impedance detected on the generator data last occurred on (b)(6) 2016 (after death) from 1267 ohms to "10000 ohms.Lead impedance was within normal limits at time of death.

Event Description

It was reported that there was no relationship between the patient's death and vns.The autopsy confirmed that the patient overdosed.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5770087
• MDR Text Key: 48788088
• Report Number: 1644487-2016-01505
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/26/2017
• Device Model Number: 106
• Device Lot Number: 4605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/08/2016
• Initial Date FDA Received: 07/05/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 08/05/2016; 09/06/2016; 09/29/2016; 10/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 31 YR